ELI-005, containing the Amphiphile vaccine adjuvant AMP-CpG, induced >25-fold higher antigen-specific T cells in the peripheral blood and exhibited potent killing of antigen-positive targets in vivo that were maintained for >5 months after vaccinationVaccine responses were highly cross-reactive to SARS-CoV-2 variants of concernAntibody responses favored TH1 isotypes with titers 265-fold higher than natural convalescent patient COVID-19 responsesResults suggest delivery of AMP-CpG to lymph nodes could be applied to rapid development of prophylactic or therapeutic vaccine candidates targeting a variety of disease-specific antigens CAMBRIDGE Mass., Sept. 22, 2021 (GLOBE NEWSWIRE) — Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, today announced positive preclinical data demonstrating that ELI-005, a protein subunit vaccine containing the lymph node-targeted Amphiphile-CpG adjuvant (AMP-CpG), induces potent cellular and humoral immunity to SARS-CoV-2 at the 2021 Vaccines Summit, being held virtually on September 20-22, 2021. “We are encouraged by these positive results for ELI-005 demonstrating that delivery of AMP-CpG adjuvant to the lymph nodes induces both cellular and humoral responses to SARS-CoV-2 antigens. This dual response is critical in developing broad protective immunity in patients,” said Peter DeMuth, Ph.D., vice president of research at Elicio Therapeutics. “The cross-reactivity to variants of concern and induction of potent potentially cross-reactive T cells are crucial benefits as the virus continues to evolve. Although we are still in the early stages of studying this adjuvant, this data shows AMP-CpG has the potential to enhance a broad spectrum of vaccines beyond SARS-CoV-2.” Elicio assessed the ability of ELI-005, containing AMP-CpG, to promote immunity directed against an admixed SARS-CoV-2 Spike receptor binding domain (RBD) protein in mice and non-human primates. Comparator vaccination with alum and unmodified CpG were included to assess immune response induction of a lymph node targeted adjuvant relative to either a depot forming or systemically distributed adjuvant. The results suggest that efficient delivery of AMP-CpG to the lymph nodes enables cellular and humoral immunity and can be applied for rapid development of prophylactic or therapeutic vaccine candidates targeting a variety of disease specific antigens. Several circulating SARS-CoV-2 strains have emerged underscoring the need for a vaccine that will protect against the variants of concern. The Spike RBD sequence is an important target for the immune response because it is the target for neutralizing antibody responses to SARS-CoV-2. These Spike antigens also contain T cell epitopes which generate cell mediated immunity. The strong T cell responses generated by ELI-005 suggest that it may enhance broad protection against these variants since most amino acid regions recognized by T cells have been conserved in variants of concern including the Beta (B.1.351) and Alpha (B.1.1.7) strains. Christopher Haqq, M.D., Ph.D., Elicio’s executive vice president, Head of Research and Development, and chief medical officer, added, “This data on ELI-005 shows the potential of our AMP platform to address various diseases by delivering immune therapies and vaccines directly to the lymph nodes, the home of the immune system, activating a potent, functional and durable immune response. We hope to bring much-needed lymph node targeted therapies to patients soon.” About the Amphiphile Platform Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants, and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes. Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases, and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships. Amphiphile platform is thought to deliver immunotherapeutics to target the lymph node directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. About Elicio Therapeutics Elicio Therapeutics is a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases. By combining expertise in immunology and immunotherapy, Elicio is engineering investigational Amphiphile immunotherapies that are intended to precisely target and fully engage the lymph nodes, the site in our bodies where the immune response is orchestrated. Elicio is engineering lymph node targeted AMPlifiers, immunomodulators, adjuvants and vaccines for an array of aggressive cancers and infectious diseases. The Amphiphile platform emerged from the laboratories of Darrell Irvine, Howard Hughes Investigator and Professor of Biomedical Engineering in the Koch Institute of Integrative Cancer Research at MIT. For more information, please visit https://elicio.com. Cautionary Note on Forward-Looking Statements This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties, assumptions and other important factors that could cause our actual results, performance or achievements to differ materially from historical results or any future results, performance or achievements expressed, suggested or implied by such forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding our plans with respect to our Phase 1/2 Dose-Escalation Study of ELI-002 (AMPLIFY-201), the ability of ELI-002 to target all seven common KRAS mutations, including G12C, the ability of our proprietary AMP platform to deliver ELI-002 directly to the lymph nodes and our belief that it may stimulate an enhanced immune response, the timing of the availability of initial safety, dose escalation, and correlative biomarker data from the Phase 1 portion of AMPLIFY-201, and the general ability and potential of our proprietary Amphiphile, or AMP, platform, to deliver investigational immunotherapeutics directly to the lymph nodes. Applicable risks and uncertainties that could cause our actual results, performance or achievements to differ materially from historical results or any future results, performance or achievements expressed, suggested or implied by our forward-looking statements include, among others: the potential that we experience slower than expected enrollment in our clinical trials, we identify serious side effects or other safety issues, we do not have clinical supply of our product candidate that is adequate in amount and quality and supplied in a timely fashion, and the inherent risks of clinical development; our limited operating history and historical losses; our need to raise capital to fund our research and development programs; the early stage nature of the development of our product candidates; our ability to obtain orphan drug designation from the FDA; competition from various competitors in the markets targeted by our product candidates, including from competitors with substantially greater resources than us; our general dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; the potential complexity of the manufacturing process for our product candidates; our ability to protect our intellectual property; our dependence on the patents we license from the Massachusetts Institute of Technology, or MIT; our compliance with healthcare laws and regulations; and risks relating to the impact on of COVID-19 or other infectious diseases on our business. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we do not undertake and specifically disclaim any obligation to update any forward-looking statements, except as required by law. Media Contact Gloria GasaaturaLifeSci Communications+1 646-970-4688ggasaatura@lifescicomms.com